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Efficacy Study of Adding Chemotherapy to Radiotherapy for Treating Bladder Cancer.

10 juli 2017 bijgewerkt door: Trans Tasman Radiation Oncology Group

A Randomised Trial of Radical Chemo/Radiotherapy vs Radiotherapy Alone in the Definitive Management of Localised Muscle Invasive TCC of the Urinary Bladder

The purpose of this study is to define the optimal management of localised transitional cell carcinoma (TCC) of the urinary bladder. The main objective is to evaluate whether chemoradiation is superior to radiotherapy alone.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Whilst concurrent chemo-radiation is increasingly being looked upon as the treatment of choice for patients referred for bladder preservation, the study by the NCI of Canada (Coppin CM, Gospodarowicz MK et al.Improved Local Control of Invasive Bladder Cancer by Concurrent Cisplatin and Pre-operative or Definitive Radiation.J. of Clinical Oncol. 14(11): 2901-2907, 1996) is the only randomised trial to show some superiority of concurrent Cisplatin and radiation treatment over radiation alone in increasing pelvic tumour control. There was no impact on overall survival. However, this study had relatively small subject numbers and included two distinct treatment options. In one group the patients were treated with a bladder sparing approach and in the other by pre-operative therapy and cystectomy with the type of definitive treatment being decided upon by both the treating Specialist and patient. At 5 years the pelvic failure rates in the radiation alone and chemo-radiation arms were 59% and 40% respectively. With half of the patients in each group having had planned cystectomy as part of their treatment regimen, the above rates of local relapse (especially in the chemo-radiation arm) are disappointing.

Given the concerns with the above study, and the continuing paucity of randomised phase III studies comparing chemo-radiation with radiation alone, there lies an opportunity for Australasian centres to take up the challenge. For this study, the proposed schedule for the chemo-radiation arm is to be the same as that being investigated in our previous phase II study (six weekly doses of Cisplatin plus radiation to a dose of 64Gy in 32 fractions over 6.5 weeks). This will be compared with radical radiation alone (64Gy in 32 fractions over 6.5 weeks).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

67

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Australië
    • New South Wales
      • Liverpool, New South Wales, Australië, 1871
        • Liverpool Hospital
      • Newcastle, New South Wales, Australië, 2298
        • Calvary Mater Newcastle
      • Penrith, New South Wales, Australië, 2751
        • Nepean Cancer Care Centre
      • Randwick, New South Wales, Australië, 2031
        • Prince of Wales Hospital
      • Wentworthville, New South Wales, Australië, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australië, 4120
        • Mater Centre - South Brisbane
      • Douglas, Queensland, Australië, 4814
        • Townsville Hospital
      • Herston, Queensland, Australië, 4029
        • Royal Brisbane Hospital
      • Tugun, Queensland, Australië, 4224
        • East Coast Cancer Centre
      • Woolloongabba, Queensland, Australië, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australië, 5000
        • Royal Adelaide Hospital
    • Tasmania
      • Launceston, Tasmania, Australië, 7250
        • Launceston General Hospital
    • Victoria
      • East Melbourne, Victoria, Australië, 3002
        • Peter MacCallum Cancer Centre
      • Geelong, Victoria, Australië, 3220
        • Andrew Love Cancer Care Centre, Geelong Hospital
      • Prahran, Victoria, Australië, 3181
        • Alfred Hospital
    • Western Australia
      • Nedlands, Western Australia, Australië, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australië, 6000
        • Royal Perth Hospital
  • Nieuw-Zeeland
      • Auckland, Nieuw-Zeeland, 1001
        • Auckland Hospital
      • Christchurch, Nieuw-Zeeland, 4710
        • Christchurch Hospital
      • Dunedin, Nieuw-Zeeland
        • Dunedin Hospital
      • Palmerston North, Nieuw-Zeeland
        • Palmerston North Hospital
      • Wellington, Nieuw-Zeeland, 7902
        • Wellington Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Histologically proven TCC of the urinary bladder. Mixed tumours comprising predominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma are also eligible.
  • Clinically and radiologically localised T2, T3 or T4a non-bulky disease (<= 7cm in maximum dimension), N0, M0.

If radiological evaluation of a lymph node is interpreted as "positive" this must be evaluated further by either lymph node sampling or percutaneous needle biopsy. Patients with histologically confirmed lymph node metastases will not be eligible.

  • Maximal TUR.

N.B. Previous:

  1. partial cystectomy;
  2. endoscopic resection of bladder tumour/s;
  3. intravesical chemotherapy; or
  4. intravesical BCG

does not exclude the patient from being eligible. However, the patient should have an adequate functioning bladder (this should be clarified with the referring Urologist and if need be voiding volumes should be measured).

  • Creatinine clearance >= 50ml/minute by calculation or measurement.
  • A white blood cell count >= 3.5 x 10^9/L with an absolute neutrophil count >= 1.5 x 10^9/L and a platelet count >= 100 x 10^9/L.
  • ECOG status of 0, 1 or 2.
  • No age limit applies provided the patient is mentally, physically and geographically capable of undergoing treatment and follow-up.
  • No significant intercurrent morbidity.

Exclusion Criteria:

  • Pure squamous carcinomas or adenocarcinomas.
  • Extensive or multifocal CIS change in the bladder.
  • T3 or T4a tumours unsuitable for curative treatment (i.e. > 7cm in any dimension), T4b, node positive and metastatic disease.
  • Presence of ureteric obstruction due to tumour infiltration at the UO not amenable to stenting.
  • Previous radiation treatment to the pelvis.
  • Previous significant pelvic surgery.
  • Significant bowel or gynaecological inflammatory disease.
  • Creatinine clearance < 50ml/minute by calculation or measurement. A white blood cell count < 3.5 x 10^9/L with an absolute neutrophil count < 1.5 x 10^9L and/or a platelet count < 100 x 10^9/L.
  • Other considerations making patient unfit for Cisplatin therapy.

  • Prior or concurrent malignancy of any other site unless disease-free for greater than 5 years, except for:

    1. non-melanoma skin cancer, and/or
    2. (a) Stage T1 well differentiated prostatic carcinoma in men, and In situ carcinoma of the cervix in women.
  • Bladder tumour - biopsy only. These patients must be referred back for more adequate resections or else should not be included

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: A
Synchronous chemo / radiation therapy
Geneesmiddel: Cisplatin
Weekly Cisplatin 35mg/m2 x 6 doses, IV administration
Andere namen:
  • Cisplatuin Ebewe, Cisplatin Injection
Straling: External beam radiation treatment
64Gy reference dose in 32 fractions over 6.5 weeks
Andere namen:
  • Straling
Actieve vergelijker: B
Radiation Alone
Straling: External beam radiation treatment
64Gy reference dose in 32 fractions over 6.5 weeks
Andere namen:
  • Straling

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Invasive local failure at 3 years
Tijdsspanne: 3 years
3 years

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Complete response (CR) rate at 3 months from randomisation
Tijdsspanne: 3 months
3 months
Disease-free survival
Tijdsspanne: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Overall survival
Tijdsspanne: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Cystectomy-free survival
Tijdsspanne: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Acute and late toxicity
Tijdsspanne: Interim analyses will be performed on an annual basis.
Interim analyses will be performed on an annual basis.
Pattern of failure (local, regional, distant)
Tijdsspanne: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Quality of life measures
Tijdsspanne: Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)
Final analysis when all patients have been followed for 3 years. (approx. 7 years from start of trial)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Trans Tasman Radiation Oncology Group

Medewerkers

National Health and Medical Research Council, Australia

Onderzoekers

  • Studie stoel: Kumar Gogna, Mater Centre - South Brisbane

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 oktober 2002

Primaire voltooiing (Werkelijk)

1 februari 2010

Studie voltooiing (Werkelijk)

1 februari 2010

Studieregistratiedata

Eerst ingediend

25 mei 2006

Eerst ingediend dat voldeed aan de QC-criteria

25 mei 2006

Eerst geplaatst (Schatting)

26 mei 2006

Updates van studierecords

Laatste update geplaatst (Werkelijk)

12 juli 2017

Laatste update ingediend die voldeed aan QC-criteria

10 juli 2017

Laatst geverifieerd

1 juli 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TROG 02.03
  • NHMRC 243100

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